Standard Induction With Basiliximab Versus No-Induction in Low Immunological Risk Kidney Transplant Recipients

Standard Induction With Basiliximab Versus No-Induction in Low Immunological Risk Kidney Transplant Recipients - Prospective Randomized Double Blind Controlled Clinical Trial

Background:

Induction therapy with IL-2 receptor antagonist (IL2-RA) is recommended as a first line agent in low immunological risk kidney transplant recipients. However, the role of IL2-RA in the setting of tacrolimus-based immunosuppression has not fully investigated

Aims:

To compare different induction therapeutic strategies with 2 doses of Basiliximab vs. no induction) in low immunologic risk kidney transplant recipients as per KFSHRC protocol (Appendix 2)

Methods:

Prospective, randomized, double blind, non-inferiority, controlled clinical trial

Expected Outcomes:

1. Primary outcomes:

   Biopsy proven acute rejection within first year following transplant

2. Secondary outcomes:

   1. Patient and graft survival at 1 year
   2. Estimated glomerular filtration rate (eGFR) at 6 months and at 12 months
   3. Emergence of de novo donor specific antibodies (DSAs)

Study Overview

• Status: Recruiting
• Conditions: Kidney Transplantation
• Intervention / Treatment: Other: Normal Saline; Drug: Basiliximab 20 milligram [Simulect]

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Phase 4

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 11211
    • Recruiting
    • King Faisal Specialist Hospital and Research Centre (KFSHRC)
    • Contact: Aziza Ajlan, B.Sc. Pharm. BCPS; Phone Number: 80341 966114647272; Email: aajlan@kfshrc.edu.sa
    • Principal Investigator: Aziza Ajlan, B.Sc. Pharm. BCPS
    • Principal Investigator: Hassan Aleid
    • Sub-Investigator: Tariq Ali
    • Sub-Investigator: Hala Joharji
    • Sub-Investigator: Ahmed Nazmi
    • Sub-Investigator: Khalid Almeshari
    • Sub-Investigator: Edward Devol
    • Sub-Investigator: Dalal Alkortas,
    • Sub-Investigator: Zinah Alabdulkarim
    • Sub-Investigator: Yaser Shah
    • Sub-Investigator: Ibrahim Alahmadi
    • Sub-Investigator: Asad Ullah
    • Sub-Investigator: Ahmed Aljedai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• • Male or female ≥ 18 years

  • Living donor

  • Low immunological risk (defined as):

    1. First (primary) transplant
    2. ≤ 4 antigen mismatches (HLA matching scheme)
    3. Negative HLA Ab screening

Exclusion Criteria:

• • High immunological risk

  • HLA identical or zero mismatched transplants
  • Receiving cyclosporin as primary maintenance immunosuppressant
  • Human immunodeficiency virus (HIV) co-infection
  • Pregnant or nursing female
  • Has received an investigational medication within the past 30 days
  • Has a known contraindication to the administration of Basiliximab
  • Suspected or known to have a serious infection
  • Multi-organ transplant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: No induction Arm	Other: Normal Saline; No-Induction
Active Comparator: Induction with basiliximab	Drug: Basiliximab 20 milligram [Simulect]; Basiliximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of biopsy proven acute rejection within first year following transplant	1 year after transplant

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of graft survival at 1 year	1 year after transplant
Rate of decline in eGFR at 6 months and at 12 months	1 year after transplant
Rate of emergence of de novo donor specific antibodies (DSAs)	1 year after transplant

Collaborators and Investigators

• Sponsor: King Faisal Specialist Hospital & Research Center

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2025

Study Registration Dates

• First Submitted: May 19, 2020
• First Submitted That Met QC Criteria: May 26, 2020
• First Posted (Actual): May 27, 2020

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Rejection; Induction; basiliximab; De no vo donor specific antibodies; Low immunological risk
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Basiliximab
• Other Study ID Numbers: RAC # 2191177

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes